Holder and deployment system for surgical heart valves

ABSTRACT

A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/700,007, filed Apr. 29, 2015, now U.S. Pat. No. 9,585,752, whichclaims the benefit of U.S. Patent Application No. 61/986,761, filed Apr.30, 2014, the entire disclosures of which are incorporated by reference.

TECHNICAL FIELD

The present application generally relates to prosthetic valves forimplantation in body channels. More particularly, the presentapplication relates to a holder for a hybrid surgical prosthetic heartvalve having a non-collapsible/non-expandable valve portion and aself-expanding anchoring stent.

BACKGROUND

In vertebrate animals, the heart is a hollow muscular organ having fourpumping chambers—the left and right atria and the left and rightventricles—each provided with its own one-way valve to ensure that blooddoes not flow in the wrong direction. The mitral valve is between theleft atrium and the left ventricle, the tricuspid valve between theright atrium and the right ventricle, the pulmonary valve is at theopening of the pulmonary artery, and the aortic valve is at the openingof the aorta above the left ventricle. The natural heart valves are eachmounted in an annulus comprising dense fibrous rings attached eitherdirectly or indirectly to the atrial and ventricular muscle fibers. Eachannulus defines a flow orifice.

Various surgical techniques may be used to repair or replace a diseasedor damaged valve. Due to aortic stenosis and other heart valve diseases,thousands of patients undergo surgery each year wherein the defectivenative heart valve is replaced by a prosthetic valve, eitherbioprosthetic or mechanical.

When the valve is replaced, surgical implantation of the prostheticvalve typically requires an open-chest surgery during which the heart isstopped and patient placed on cardiopulmonary bypass (a so-called“heart-lung machine”). In one common surgical procedure, the diseasednative valve leaflets are excised and a prosthetic valve is sutured tothe surrounding tissue at the valve annulus. Because of the traumaassociated with the procedure and the attendant duration ofextracorporeal blood circulation, some patients do not survive thesurgical procedure or die shortly thereafter. Due to these risks, asubstantial number of patients with defective valves are deemedinoperable because their condition is too frail to withstand theprocedure. By some estimates, about 30 to 50% of the subjects sufferingfrom aortic stenosis who are older than 80 years cannot be operated onfor aortic valve replacement.

Percutaneous and minimally-invasive surgical approaches, some of whichavoid cardiopulmonary bypass altogether in “beating heart” procedures,are garnering intense attention. Although these remote implantationtechniques have shown great promise for treating certain patients,replacing a valve via surgical intervention and bypass is still thepreferred treatment procedure. One hurdle to the acceptance of remoteimplantation is resistance from doctors who are anxious about convertingfrom an effective, if imperfect, regimen to a novel approach thatpromises great outcomes but is relatively foreign. In conjunction withthe understandable caution exercised by surgeons in switching to newtechniques of heart valve replacement, regulatory bodies around theworld are moving slowly as well.

Accordingly, there is a need for a prosthetic valve that can besurgically implanted in a body channel in a more efficient procedure soas to reduce the time required on extracorporeal circulation. Onesolution especially for aortic valve replacement is provided by theEdwards Intuity valve system available from Edwards Lifesciences ofIrvine, Calif. Aspects of the Edwards Intuity valve system are disclosedin U.S. Pat. No. 8,641,757 to Pintor, et al. The Edwards Intuity valveis a hybrid of a surgical valve and an expandable stent that helpssecure the valve in place in a shorter amount of time. The implantprocess only requires three sutures which reduces the time-consumingprocess of tying knots. A delivery system advances the Edwards Intuityvalve with the stent at the leading end until it is located within theleft ventricle, at which point a balloon inflates to expand the stentagainst the ventricular wall. The long handle and delivery system designfacilitate access through smaller incisions (mini-sternotomy or rightanterior thoracotomy) than with conventional full sternotomies.

There remains a need for further innovative approaches like the EdwardsIntuity valve system that combine the proven effectiveness of existingsurgical valves and shorten the implant procedure time.

SUMMARY

The present application discloses prosthetic valves and methods of usefor replacing a defective native valve in a human heart. Certainembodiments are particularly well adapted for use in a surgicalprocedure for quickly and easily replacing a heart valve whileminimizing time using extracorporeal circulation (e.g., bypass pump). Inparticular, the application discloses an advantageous system and methodfor holding and delivering a hybrid prosthetic heart in less time thanpreviously was possible.

One aspect of the application is a combination of a prosthetic heartvalve for implant at a heart valve annulus and a holder therefor. Thecombination includes a “hybrid” prosthetic heart valve having a valvemember and a self-expandable anchoring stent. The valve member includesa non-expandable, non-collapsible annular support structure defining aflow orifice and an inflow end defining an inflow direction with anoutflow direction opposite thereto. The valve member also has valveleaflets attached to the support structure and mounted to alternatelyopen and close across the flow orifice. The self-expandable anchoringstent has a first or outflow end extending around the flow orifice andconnected to the valve member at the inflow end of the support structureso that the first end maintains a fixed diameter. The anchoring stentalso has a second or inflow end projecting in the inflow direction awayfrom the support structure and having a relaxed, expanded shape defininga first peripheral size.

In a first embodiment, the valve holder connects by a first suture tothe prosthetic heart valve, wherein the first suture extends around thesecond end of the anchoring stent and is placed under tension toconstrict the second end to a second peripheral size smaller than thefirst peripheral size. The first suture desirably passes over a singlecutting well on the valve holder such that severing the first suture atthe single cutting well releases the tension therein and permits thesecond end of the anchoring stent to expand toward its first peripheralsize.

In a second embodiment, the valve holder connects by a first suture tothe prosthetic heart valve, wherein the first suture has a first freeend attached to the valve holder, a middle portion that extends in afirst length in the inflow direction, in a second length around theentire inflow end of the anchoring stent, and in a third length back tothe valve holder alongside the first length, the first suture furtherhaving a fourth length that passes over a cutting well on the valveholder and ends in a second free end attached to the valve holder suchthat when the two free ends are attached to the valve holder the firstsuture is under tension and constricts the inflow end from a relaxedsize to a smaller size.

In either valve-holder connection embodiment, the anchoring stent has afabric covering, and wherein the first suture passes in a serpentinefashion through the fabric covering around the second or inflow end ofthe anchoring stent. The valve holders may be further connected by asecond suture to the prosthetic heart valves, each valve holderincluding a plurality of legs (preferably three) that contact the valvemember at the same number of locations having fabric incorporated intothe valve member, and wherein the second suture passes circumferentiallyaround the valve holder and threads through the fabric at the locations.Both the first and second sutures desirably pass over a single cuttingwell on the valve holder such that severing the first and second suturesat the single cutting well simultaneously releases the tension in thefirst suture, permitting the second end of the anchoring stent to expandtoward its first peripheral size, and disconnects the valve holder fromthe prosthetic heart valve. The valve member support structurepreferably has three commissure posts projecting in the outflowdirection and three cusps therebetween that arc in the inflow direction,and the valve leaflets are flexible and partly supported by thecommissure posts of the support structure. In this configuration, thevalve holder includes a central hub and three legs that angle outwardand in the inflow direction to contact the valve member at the threecusps, and wherein the first suture is tied at two free ends to aterminal foot of one of the holder legs. Also with this valveconfiguration, the valve holders further may be connected by a secondsuture to the prosthetic heart valve that passes circumferentiallyaround the valve holder and threads through the fabric at the threecusps. The second suture may be tied at first and second free ends tothe holder, and in between passes circumferentially around the hub ofthe holder and descends down each of the three legs to pass through twoholes at a terminal foot thereof. The second suture is also preferablythreaded through the fabric at each of the three cusps between the twoholes, and circles completely around each leg between the hub and therespective foot.

A method of deploying a prosthetic heart valve for implant at a heartvalve annulus disclosed herein comprises:

providing a prosthetic heart valve having a valve member with anon-expandable, non-collapsible annular support structure and valveleaflets mounted thereto to alternately open and close, and aself-expandable anchoring stent connected to the valve member at aninflow end of the support structure and having an inflow end projectingin the inflow direction away from the support structure, the prostheticheart valve being secured to a valve holder by a first suture thatattaches at two free ends to the valve holder and extends around theentire inflow end of the anchoring stent under tension and constrictsthe inflow end from a relaxed size to a smaller size, the first suturehaving a middle portion that passes over a cutting well on the valveholder;

advancing the prosthetic heart valve to the heart valve annulus; and

severing the first suture at the cutting well to release the tensiontherein and permit the inflow end of the anchoring stent to expandtoward its relaxed size.

The method may also involve a second suture connecting the prostheticheart valve to the holder, wherein both the first and second suturespass over the cutting well on the valve holder such that severing thefirst and second sutures at the cutting well simultaneously releases thetension in the first suture, permitting the inflow end of the anchoringstent to expand toward its first peripheral size, and disconnects thevalve holder from the prosthetic heart valve. The valve holderpreferably includes a central hub and a plurality of legs that contactthe valve member at the same number of locations having fabricincorporated into the valve member, wherein the second suture passescircumferentially around the valve holder and threads through the fabricat the locations. The second suture is desirably tied at first andsecond free ends to the holder, and in between passes circumferentiallyaround the hub of the holder and descends down each of the legs to passthrough two holes at a terminal foot thereof. The valve member supportstructure preferably has three commissure posts projecting in theoutflow direction and three cusps therebetween that arc in the inflowdirection, and the second suture is threaded through the fabric at eachof the three cusps and between the two holes, and wherein the secondsuture circles completely around each leg between the hub and therespective foot.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be explained and other advantages and featureswill appear with reference to the accompanying schematic drawingswherein:

FIG. 1 shows both exploded and assembled views of an exemplary hybridprosthetic heart valve (hereinafter, “heart valve”) for which the holderand deployment system of the present application is designed, withfabric coverings removed from an anchoring stent for clarity;

FIG. 2 is an exploded view of the expandable anchoring stent and itsfabric coverings which form a component of the heart valve in FIG. 1;

FIG. 3 shows both exploded and assembled views of the finished heartvalve showing the fabric-covered anchoring stent in its expanded,deployed state;

FIG. 4A is an exploded view of an exemplary valve holder above the heartvalve with the anchoring stent expanded, and FIG. 4B shows the valveholder coupled to the heart valve with a pair of connecting sutures, oneof which maintains the anchoring stent in its constricted, deliverystate;

FIGS. 5A-5C are perspective and top plan views of the exemplary valveholder prior to coupling with the heart valve and showing the initialattachment locations of the first free ends of the pair of connectingsutures to the holder;

FIGS. 6-11 illustrate a number of steps taken to couple the valve holderto the heart valve using an upper connecting suture, wherein:

FIG. 6 shows the valve holder exploded above the heart valve and theinitial path of the upper connecting suture passed downward through aportion of the fabric of the heart valve;

FIGS. 7A and 7B are perspective and top plan views of the valve holderin contact with the heart valve and illustrating the path of the upperconnecting suture after having secured a first leg of the holder to theheart valve;

FIGS. 8A and 8B illustrate the path of the upper connecting suture as ittraverses between the first leg of the holder to a second leg where itis again secured to the heart valve;

FIGS. 9A and 9B illustrate the path of the upper connecting suture afterhaving secured the second leg of the holder to the heart valve and wrapsaround a cutting well provided on the second leg of the holder;

FIGS. 10A and 10B illustrate the path of the upper connecting suture asit traverses between the second leg of the holder to a third leg whereit is again secured to the heart valve;

FIGS. 11A and 11B illustrate a second free end of the upper connectingsuture after being secured to the holder at the first leg;

FIGS. 12-13 illustrate a number of steps taken to further couple thevalve holder to the heart valve and constrict the anchoring stent usinga lower connecting suture, wherein:

FIGS. 12A and 12B are two perspective views of the valve holder securedto the heart valve via the upper connecting suture and illustrating theinitial path of the lower connecting suture as it passes downward fromthe second leg of the holder through fabric of the heart valve to alower end of the anchoring stent;

FIGS. 12C and 12D illustrate the path of the lower connecting suture asit circumscribes the lower end of the anchoring stent and passes backupward to the second leg of the valve holder;

FIG. 12E illustrates the path of the lower connecting suture as it wrapsaround the cutting well provided on the second leg of the holder;

FIG. 12F illustrates conversion of the anchoring stent from its expandedto its constricted state by tensioning the lower connecting suture;

FIGS. 13A and 13B illustrate a second free end of the lower connectingsuture again secured to the valve holder;

FIGS. 14A and 14B are top and bottom plan views, respectively, of thevalve holder secured to the heart valve using the connecting sutures;

FIGS. 15A-15C are several partial sectional elevational views of thethree valve holder legs having the connecting sutures attached thereto;

FIGS. 16A and 16B are perspective views at two different angles of thevalve holder and heart valve assembly shown in phantom so as to betterillustrate the pathway of the connecting sutures;

FIG. 17A illustrates a scalpel descending into the cutting well on thesecond leg of the valve holder to sever the two connecting sutures, andFIG. 17B shows the consequent conversion of the anchoring stent from itsconstricted to its expanded state and separation of the valve holderfrom the heart valve;

FIG. 18A is an elevational view of the valve holder secured to analternative hybrid prosthetic heart valve using connecting sutures; and

FIG. 18B is an elevational view of the assembly of FIG. 18A aftersevering of the connecting sutures to permit an anchoring stent of theheart valve to expand.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The present disclosure provides a valve holder for hybrid prostheticheart valves delivered by open-heart surgery, but which include featuresthat decrease the duration of the treatment procedure. The prostheticheart valves of the present invention are primarily intended to bedelivered and implanted using surgical techniques, including theaforementioned open-heart surgery. There are a number of approaches insuch surgeries, all of which result in the formation of a direct accesspathway to the particular heart valve annulus. For clarification, adirect access pathway is one that permits direct (e.g., naked eye)visualization of the heart valve annulus.

The “hybrid” prosthetic heart valve has both non-expandable andexpandable portions; specifically, an expandable anchoring stent orstent coupled to a non-expandable valve member. With this type of valve,the duration of the anchoring operation is greatly reduced as comparedwith a typical sewing procedure utilizing an array of sutures that mustbe knotted. The expandable anchoring stent may simply be radiallyexpanded outward into contact with the implantation site, or may beprovided with additional anchoring means, such as barbs. As stated,open-heart approach and cardiopulmonary bypass familiar to cardiacsurgeons are used. However, due to the expandable anchoring stent, thetime on bypass is greatly reduced by the relative speed of implant incontrast to the previous time-consuming knot-tying process. As mentionedabove, an exemplary hybrid prosthetic heart valve is disclosed in U.S.Pat. No. 8,641,757 to Pintor, et al., filed Jun. 23, 2011, to whichpriority is claimed, and which is hereby expressly incorporated byreference herein.

For definitional purposes, the terms “stent” or “anchoring stent” referto a structural component that is capable of anchoring to tissue of aheart valve annulus. The coupling stents described herein are mosttypically tubular stents, or stents having varying shapes or diameters.A stent is normally formed of a biocompatible metal frame, and may beformed of a plastically-expandable material such as stainless steel orcobalt-chromium, or a self-expandable material such as Nitinol. In thecontext of the present invention the stents are preferably made fromlaser-cut tubing of a self-expandable metal. It is conceivable, however,that the coupling stent could be separate self-expanding clamps or hooksthat do not define a continuous periphery. Although such devicessacrifice some contact uniformity, and speed and ease of deployment,they could be configured to work in conjunction with a particular valvemember.

The term “valve member” refers to that component of a heart valve thatpossesses the fluid occluding surfaces to prevent blood flow in onedirection while permitting it in another. As mentioned above, variousconstructions of valve members are available, including those withflexible leaflets and those with rigid leaflets, or even a ball and cagearrangement. The leaflets may be bioprosthetic, synthetic, metallic, orother suitable expedients. In a preferred embodiment, the non-expandablevalve member is an “off-the-shelf” standard surgical valve of the typethat has been successfully implanted using sutures for many years, suchas the Carpentier-Edwards PERIMOUNT Magna® Aortic Heart Valve availablefrom Edwards Lifesciences of Irvine, Calif., though the autonomousnature of the valve member is not absolutely required. In this sense, a“off-the-shelf” prosthetic heart valve is suitable for stand-alone saleand use, typically including a non-expandable, non-collapsible supportstructure having a sealing ring capable of being implanted using suturesthrough the sealing ring in an open-heart, surgical procedure.

As a point of further definition, the term “expandable” is used hereinto refer to a component of the heart valve capable of expanding from afirst, delivery diameter to a second, implantation diameter. Anexpandable structure, therefore, does not simply mean one that mightundergo slight expansion from a rise in temperature, or other suchincidental cause such as fluid dynamics acting on leaflets orcommissures. Conversely, “non-expandable” should not be interpreted tomean completely rigid or a dimensionally stable, as some slightexpansion of conventional “non-expandable” heart valves, for example,may be observed.

An aortic valve replacement would be implanted in, or adjacent to, theaortic annulus, while a mitral valve replacement will be implanted atthe mitral annulus. Certain features of the present invention areparticularly advantageous for an aortic valve replacement. However,unless the combination is structurally impossible, or excluded by claimlanguage, any of the heart valve embodiments described herein could beimplanted in any body channel.

FIG. 1 shows both exploded and assembled views of an exemplary hybridprosthetic heart valve 20 (hereinafter, “heart valve”) having a valvemember 22 and an expandable anchoring stent 24 with fabric coveringsremoved for clarity. FIG. 2 is an exploded view of the expandableanchoring stent 24 and its fabric coverings 26, 28, with thecloth-covered stent 24′ seen at the bottom, while FIG. 3 shows bothexploded and assembled views of the finished heart valve 20 with thefabric-covered anchoring stent 24′ in its expanded, deployed state.

The exemplary hybrid prosthetic heart valve 20 of the presentapplication desirably includes the valve member 22 with the anchoringstent 24 attached to and extending from an inflow end thereof. The valvemember 22 is desirably non-collapsible and non-expandable, while theanchoring stent 24 may expand from a contracted state into the expandedstate shown, as will be described. In the illustrated embodiment, theanchoring stent 24 features a series of axial struts with achevron-shaped pattern of circumferential struts therebetween whichexpand when unrestrained to the shape shown in FIG. 1.

The valve member 22 preferably includes a plurality of leaflets 30supported by and extending inward from a cloth-covered inner supportframe (not shown) that defines upstanding commissure posts 32intermediate the same number of cusps 34. There are typically threecommissure posts 32 alternating with three cusps 34 to support threeleaflets 30 along each of the cusps, though only two or more than threeare known. The leaflets 30 provide the occluding surfaces for theprosthetic heart valve 20 which ensure one-way blood flow through thevalve. The illustrated valve member 22 includes a peripheral sealingring 36 surrounding the inflow end thereof. The heart valve 20 isdesirably for implantation at the aortic annulus and the sealing ring 36therefore preferably has an undulating up and down shape around itsperiphery to match the native aortic annulus.

It should be noted that a sealing ring per se may not be necessary withthe present heart valve as the primary function of such a component isnormally to provide a platform through which to pass a number ofanchoring sutures around the valve periphery. However, sutures are notused to implant the hybrid heart valve 20 except perhaps for a smallnumber (e.g., 3) guide sutures. For instance, several tabs extendingoutward from the valve structure could be used for anchoring the guidesutures which take the place of the sealing ring for that purpose. Tohelp prevent paravalvular leaking, a peripheral seal such as a fabricskirt as described below may be added in place of the sealing ring.

The leaflets 30 are desirably flexible, preferably bioprostheticleaflets. For example, the valve leaflets 30 may be tissue from anotherhuman heart (cadaver), a cow (bovine), a pig (porcine valve) or a horse(equine). In some embodiments, the leaflets are pericardium or treatedpericardium, for example, bovine, porcine, equine, or kangaroo.Alternatively, the valve member may comprise mechanical componentsrather than biological tissue. Although an autonomous (e.g., capable ofstand-alone surgical implant) flexible leaflet valve member 22 isdescribed and illustrated, alternative valve members that have rigidleaflets, or are not fully autonomous may be substituted.

In one embodiment, the valve member 22 comprises a Carpentier-EdwardsPERIMOUNT Magna® Aortic Heart Valve available from Edwards Lifesciencesof Irvine, Calif. In another embodiment, the valve member 22 comprises aPERIMOUNT Magna® Aortic valve subjected to tissue treatment that permitsdry packaging and sterilization, and that eliminates the need to rinse apreservative from the valves before implantation.

For bioprosthetic valves, an exemplary process includes storing theprosthetic heart valve 20 in a preservative solution after manufactureand prior to use. A preservative such as glutaraldehyde is providedwithin a storage jar. This “wet” storage arrangement applies to theillustrated heart valve 20 shown, which includes bioprosthetic leaflets.However, as mentioned above, the heart valve could also be used withouta preservative solution for bioprosthetic leaflets that have been dried,for example, using suitable tissue treatments from Edwards Lifesciences,and also for mechanical valves.

The general function of the anchoring stent 24 is to provide the meansto attach the prosthetic valve member 22 to the native aortic root. Thisattachment method is intended as an alternative to the present standardsurgical method of suturing aortic valve bio-prostheses to the aorticvalve annulus, and is accomplished in much less time. Further, thisattachment method improves ease of use by eliminating most if not allsuturing and knot tying. The anchoring stent 24 is formed of aself-expandable metallic member desirably covered by a polyester fabricto help seal against paravalvular leakage and promote tissue ingrowthonce implanted within the annulus.

In a preferred embodiment, an inner fabric layer 26 immediately coveringthe anchoring stent 24 (inner fabric layer) comprisespolytetrafluoroethylene (PTFE) cloth, such as TEFLON® PTFE (DuPont,Wilmington, Del.), although other biocompatible fabrics may be used.More particularly, the fabric 26 is a PTFE flat yarn. A sealing flange28 comprises a much thicker material to provide prevention ofparavalvular leakage. For instance, the sealing flange 28 is formed of aplush polymer, and made of polyethylene terephthalate (PET). Morepreferably, the material of the sealing flange 28 has a base yarn whichis flat yarn 40/27, and a loop yarn extending therefrom made from PET70/12 textured yarn both obtained from Atex Technologies Inc. ofPinebluff, N.C. The thickness of the sealing flange 28 material isdesirably about 1.2 mm, uncompressed, while the thickness of the fabric26 may be 50% or less of that. In alternative embodiments, differentmaterials can be used from the covering layer 26 and the sealing flange28, such as PTFE/cloth, cloth/cloth, or PTFE or cloth for the coveringlayer 26 and a swellable hydrophilic polymer such as an acrylic for thesealing flange 28. The sealing flange 28 is shown located around theupper or outflow end of the anchoring stent 24, although it may alsocover the entire anchoring stent or be located around just the lower orinflow end.

As seen schematically in FIGS. 1-3, the valve member 22 preferablyattaches to the anchoring stent 24 via a plurality of attachment sutures40. The sutures 40 desirably loop around an upper circumferential strut42 on the anchoring stent 24 and pass through fabric at the inflow endof the valve member 22. There are a number of ways to connect the twocomponents such as shown and described in U.S. Pat. No. 8,641,757 toPintor, et al., the entire disclosure which is incorporated byreference, mentioned above.

FIG. 4A is an exploded view of an exemplary valve holder 50 above theheart valve 20 with the fabric-covered anchoring stent 24′ expanded. Thevalve holder 50 includes a central tubular hub 52 having internalthreads 54, and a plurality of stabilizing legs 56 projecting axiallyand radially outward therefrom. Preferably, there are three stabilizinglegs 56 each of which contacts and attaches to a cusp 34 of the valvemember 22 between commissure posts 32. The valve holder 50 secures withsutures to the valve member 22 from the time of manufacture to the timeof implant, as seen in FIG. 4B, and is stored with the valve member. Inone embodiment, the holder 22 is formed of a rigid polymer such aspolypropylene that is transparent to increase visibility of an implantprocedure. The holder 22 exhibits relatively wide openings between thestabilizing legs 56, which provide a surgeon good visibility of thevalve leaflets 30. The transparency of the legs further facilitatesvisibility and permits transmission of light therethrough to minimize orreduce shadows. It should be noted that the exemplary heart valve 20 isgenerally symmetric about three radial sections with three cusps, threecommissures, and three flexible leaflets, matching a holder 22 withthree legs 56. However, other configurations of heart valves areavailable and the holder may have more or fewer legs as necessary.

FIG. 4B shows the valve holder 50 coupled to the heart valve 20 with apair of connecting sutures 60, 62, one of which maintains the anchoringstent 24′ in its constricted, delivery state. As will be explainedbelow, an upper connecting suture 60 secures each of the three legs 56to one of the cusps 34 of the valve member 22, while a lower connectingsuture 62 extends downward from one of the legs and is threadedperipherally around a lower end 64 of the anchoring stent 24′. Tensionon the lower connecting suture 62 constricts the anchoring stent 24′,and the suture is then tied off to maintain the anchoring stent in itsdelivery state, as shown.

Preferably, there is one upper connecting suture and one lowerconnecting suture, as shown, although only a single connecting suture ormore than one of each are also possible. As will be explained, at leastone suture functions to securely attach the holder to the heart valve,and one functions to maintain a self-expanding stent constricted. Thesefunctions may be accomplished with a single suture, though for the sakeof stability and ease of assembly two are used, as is explained herein.Furthermore, although a particular path for both upper and lowerconnecting sutures are used for the particular holder shown, othersuture paths can be used with other holders.

FIGS. 5A-5C best illustrate specific features of the exemplary valveholder 50. As explained above, the holder 50 preferably includes thecentral hub 52 and three stabilizing legs 56 a, 56 b, and 56 c. For thepurpose of explaining a series of steps coupling the holder 52 theprosthetic heart valve 20, the holder includes a first leg 56 a, asecond leg 56 b, and a third leg 56 c, moving clockwise around an axisof the holder as seen in the plan view of FIG. 5C. The connectingsutures 60, 62 are shown attached at respective first free ends to theholder prior to their use in attaching the heart valve 20. Moreparticularly, the upper connecting suture 60 has a first end tied off onthe first leg 56 a, and the lower connecting suture 62 has a first endtied off on the second leg 56 b.

The three legs 56 a, 56 b, and 56 c are identical and evenly spacedcircumferentially around the central hub 52 (e.g., 120° spacingtherebetween) in the illustrated example. With reference to FIG. 5B,each leg 56 has an upper bridge portion 66 that initially projectsdirectly radially outward from the hub 52 and a leg portion 68 thatangles downward and outward. In one embodiment, the angle that each legportion 68 makes with a central axis through the holder is between about10°-45°. The bridge portion 66 comprises a pair of axially-oriented(e.g., vertical) outer walls 70 that are generally parallel to andextend upward over a radially-oriented cutting guide or well 72. Alongthe top edge of each of the outer walls 70 is formed a small notch 74the purpose of which will become clear below. Additionally, a smallaperture 76 extends through each of the outer walls 70 just below itsnotch 74. As seen in FIG. 5A, each leg portion 68 has a substantiallyrectangular cross-section on a majority of its length as it extendsdownward from the bridge portion 66, though other cross-sections arecontemplated. A lower end of each leg portion 68 terminates in anoutwardly-angled flange 78 defining a pair of through holes 80, and adownwardly-directed flange 82. A channel 84 formed between the flange78, 82 receives a portion of the cusps 34 of the valve member 22, aswill be seen. The downwardly-directed flange 82 may be eliminated suchthat only the outwardly-angled flanges 78 contact the valve cusps 34.Two through holes 80 open on their lower ends in the channel 84.

The upper connecting suture 60 has a first free end 86 that is tied toone of the outer walls 70 of the first holder leg 56 a, as best seen inFIG. 5A. Specifically, the first free end 86 loops through the smallaperture 76 and over the notch 74 right above it, and is tied off with aknot. The upper connecting suture 60 is connected to a left-hand one ofthe two outer walls 70, as looking radially inward at the first leg 56a. The lower connecting suture 62 has a first free end 88 tied to theoutwardly-angled flange 78 in the second holder leg 56 b, as best seenin FIG. 5B (and also FIG. 15A). In particular, the first free end 88loops through a right-hand one of the through holes 80 in the flange 78and is tied off with a knot. As will be explained below, both of theconnecting sutures 60, 62 are respectively threaded down through theheart valve 20 and around various features on the holder 50, andultimately a second free end is tied at the same location as the firstfree and. In this regard each of the connecting sutures 60, 62 issecured at both its free ends to the holder 50 and has a middle portionin between.

FIGS. 6-11 illustrate a number of steps that an assembler takes tocouple the valve holder 50 to the heart valve 20 using the upperconnecting suture 60. Initially, FIG. 6 shows the valve holder 50exploded above the heart valve 20 with the first leg 56 a facing outfrom the page. In each of the succeeding drawings (e.g., FIGS. 7A-11B),the holder 50 abuts the valve 20 and the suture 60 is shownprogressively securing them together. It should be noted that theassembly rotates in the elevational “A” series of views for clarity,while it remains stationary as looking from above in the “B” series ofviews.

As explained above, the suture 60 is first tied off at a left hand oneof the vertical outer walls 70 on the first leg 56 a. From there, asseen in FIGS. 7A and 7B, the assembler passes the suture 60 to theinside of the first leg 56 a, crossing over from the left side to theright side, and then emerging to the outside of the leg and extendingdownward through one of the through holes 80 in the outwardly-angledflange 78. The suture 60 continues downward and is threaded through afabric portion of the heart valve 20. More particularly, the valvemember 22 has fabric edge 90 that defines a portion of thefabric-covered support frame. The assembler threads the suture 60through this fabric edge 90 at the cusps 34 of the valve member 22. Eachleg 56 contacts and is secured to a mid-portion of each of the cusps 34of the valve member 22. As will be explained, each suture 60 passesdownward through the first through hole 80 in the flange 78, through thefabric edge 90, and back up through the second through hole 80, as seenin FIG. 7A.

FIGS. 7A and 7B illustrate the next step of threading the upperconnecting suture 60 around the valve holder 50. After passing down andback up through the holes 80 in the flange 78 of the first leg 56 a, andthrough the fabric edge 90, the assembler wraps the suture 60 around theleft side of the first leg and around the inside thereof, crossing overthe first length of the suture to exit on the right side of the leg, asshown. From there, the assembler passes the suture 60 in acounterclockwise manner (looking from above) around the cylindrical hub52 and through an upwardly-opening notch 92 provided in a first rail 94a that extends outward from the hub between the first and second legs 56a, 56 b.

Now with reference to FIGS. 8A and 8B, the suture 60 angles downwardfrom the notch 92 and passes underneath the upper bridge portion 66 ofthe second holder leg 56 b. The suture 60 wraps around the inside of thesecond leg 56 b, and emerges to the front thereof. The suture 60 is thenis then passed downward through the right-hand hole 80 of the flange 78,through the fabric edge 90 of the valve 20, and back up through theleft-hand hole. At this point, the upper connecting suture 60 hassecured both the first and second legs 56 a, 56 b to the valve 20, andis shown dangling loose; however, in practice the assembler typicallymaintains some tension on the suture.

In the next step, as seen in FIGS. 9A and 9B, the assembler brings theupper connecting suture 60 around the inside of the second leg 56 b,crossing over the strand of the suture that previously passed to theinside of the leg. He or she then loops the suture 60 counterclockwiseonce over the upper bridge portion 66, making sure that the suturepasses through both of the notches 74 in the outer walls 70. In thisway, the suture crosses over the cutting well 72 defined between theouter walls 70 in the second leg 56 b. The connecting suture 60 islooped underneath the bridge portion 66 and again continues in acounterclockwise fashion around the hub 52 and is positioned in thenotch 92 of a second rail 94 b between the second and third legs 56 b,56 c.

Next, as seen in FIGS. 10A and 10B, the assembler wraps the suture 60behind or to the inside of the third leg 56 c, and around the outside ofthe leg and passes it downward through the right-hand hole 80 in theflange 78. As before, the suture 60 passes downward through the fabricedge 90 of the valve 20 and upward through the left-hand hole 80, thussecuring the third leg 94 c to the valve 20. As with the other two legs,the assembler then wraps the suture 60 around the left side and to theinside of the third leg 56 c, and angles it in a counterclockwisedirection over the notch 92 of a third rail 94 c between the third andfirst legs 56 c, 56 a.

FIGS. 11A and 11B show the upper connecting suture 60 as it extends fromthe third rail 94 c to the first leg 56 a and its second free end 96 istied off at a knot (also seen in FIG. 15C). The knot is tied off at thesmall aperture 76 on one of the outer walls 70 of the first leg 56 a,along with the first free end 86 of the connecting suture 60, as wasshown in FIGS. 5A and 5B. In the final assembly, there is a singleconnecting suture 60 wrapped around the holder 50 and securing the threelegs 56 at the three cusps 34 of the valve 20. Further, a single-cutrelease point is provided where the suture 60 wraps around the bridgeportion 66 and over the cutting well 72 on the second leg 56 b. Sincethe two free ends 86, 96 of the suture 60 tie off on the holder,severing the middle portion at the cutting well 72 permits the holder 50to be pulled free of the valve 20, with the suture 60 relatively easilysliding through out of the fabric edges 90.

Once the upper connecting suture 60 secures the holder 50 to the heartvalve 20, the lower connecting suture 62 is attached and the anchoringstent 24 constricted, as will be explained with reference to FIGS.12-13. However, it should be noted that the configuration shown in FIGS.11A and 11B wherein a single connecting suture 60 attaches the holder 50to the valve 20 at three cusp locations and features a single-cutrelease can be used for valves other than the exemplary embodiment. Thatis, the valve 20 may include an anchoring stent that is plasticallyexpandable as opposed to being self-expandable. For instance, the valvesshown in U.S. Pat. No. 8,641,757 to Pintor, et al. have balloonexpandable anchoring stents, and the holder 50 and upper connectingsuture 60 configuration disclosed herein could be used to manipulatethose valves. In that case, a lower connecting suture could be omitted,as its purpose is to constrict a self-expandable anchor stent. It shouldalso be noted that the valve may not have an anchor stent at all, andthe holder 50 and upper connecting suture 60 configuration disclosedherein could be used to manipulate “standard” as opposed to “hybrid”prosthetic heart valves.

With reference to FIGS. 12A and 12B an initial path of the lowerconnecting suture 62 is shown. The reader will recall that the firstfree end 88 is tied to the outwardly-angled flange 78 in the secondholder leg 56 b, as seen in FIG. 5B. The assembler uses a needle 100 tothread the suture 62 downward through the peripheral sealing ring 36 ofthe heart valve 20, which is just outside the fabric edge 90 thatdefines a portion of the fabric-covered support frame. The suture 62continues to the outside of the valve 20 and threads through a portionof the fabric at a lower end of the anchoring stent 24. In theillustrated embodiment, the needle 100 and suture 62 pass through thefabric layer 26 immediately covering the anchoring stent 24 (innerfabric layer), although it may also be that the sealing flange 28extends or covers the lower end of the stent. In any event, the path ofthe suture 62 is substantially straight down from the sealing ring 36 tothe lower edge of the fabric-covered stent 24.

FIGS. 12C and 12D illustrate the lower connecting suture 62 being sewnaround the lower end of the anchoring stent 24 (through the fabriccovering). The assembler uses the needle 100 to thread the suture 62 inand out of the stent 24 in a serpentine fashion, around the peripherythereof, it comes full circle adjacent to the starting point below thesecond leg 56 b. Prior to this threading step, the stent 24 has beenconstricted by an external force, such as with a separate cinch orfixture (not shown) that encircles the lower end of the stent and forcesit inward. The suture 62 emerges to the outside of the stent 24 andpasses directly upward to the left-hand hole 80 of the flange 78 in thesecond leg 56 b, again passing through the sealing ring 36. At thisstage the anchoring stent 24 remains in an expanded configuration,flared slightly outwardly.

Now with reference to FIGS. 12E and 12F, the lower connecting suture 62circles behind or to the inside of the second leg 56 b, and then wrapsaround the upper bridge portion 66 thereof, through both of the notches74 in the outer walls 70. In this way, both the upper and lowerconnecting sutures 60, 62 traverse the cutting well 72 on the same leg56 b. FIG. 12F illustrates the free end of the connecting suture 62again being passed behind or to the inside of the second leg 56 a.

Finally, with reference to FIGS. 13A and 13B, a second free end 102thereof is again secured to the right-hand hole 80 in theoutwardly-angled flange 78 in the second leg 56 b. Both the first andsecond free ends 88, 102 are thus secured to the holder at the samelocation. Some tension will be applied to the lower connecting suture 62before securing it in this manner so that it can maintain the stent 24in its constricted state without allowing any recoil. The externalfixture (not shown) used to constrict the stent 24 can then be removed.

FIGS. 14A and 14B are top and bottom plan views, respectively, of thevalve holder 50 secured to the heart valve 20 using the connectingsutures 60, 62. The release of the holder 50 from the valve 20 andconversion of the anchoring stent 24 from its contracted to its expandedstates are enabled by severing the sutures 60, 62 at the cutting well 72in the second leg 56 b, in a single-point release configuration. Thein-and-out or serpentine weave of the lower connecting suture 62 throughthe stent 24 is seen in FIG. 14B.

FIGS. 15A-15C are several partial sectional elevational views of thethree valve holder 50 legs further illustrating the connecting suturesattached thereto. The second leg 56 b is seen from one side in FIG. 15Ato show the knot at which the first and second free ends 88, 102 of thelower connecting suture 62 attach. The downward path of the lowerconnecting suture 62 through the sealing ring 36 and to the lower end ofthe stent 24 is also seen. FIG. 15A also shows the two sutures 60, 62wrapping around the upper bridge portion 66 and through both of thenotches 74 in the outer walls 70 of the second leg 56 b. As mentioned,both the upper and lower connecting sutures 60, 62 therefore traversethe cutting well 72 on the second leg 56 b. FIG. 15B shows the third leg56 c from its left side, illustrating the upper connecting suture 60passing downward around the leg and through the holes 80 in the flange78 so as to be secured to the fabric edge 90 at the valve cusps 34.Finally, FIG. 15C shows the first and second free ends 86, 96 of theupper connecting suture 60 tied off at the small aperture 76 on one ofthe outer walls 70 of the first leg 56 a. Again, the suture 60 wrapsaround the leg and passes down through the flange 78 to secure at thefabric edge 90 of the valve 20.

FIGS. 16A and 16B are perspective views at two different angles of thevalve holder 50 and heart valve 20 assembly shown in phantom so as tobetter illustrate the pathway of the connecting sutures 60, 62. Theseviews more clearly illustrate how the upper connecting suture 60encircles the holder 50, while the lower connecting suture 62 encirclesthe lower end of the stent 24, and both converge at the single cuttingwell 72 for a one-cut release of both the holder and stent.

FIG. 17A illustrates a scalpel 110 descending into the cutting well 72on the second leg 56 b of the valve holder 50. This action severs thetwo connecting sutures 60, 62, thus disengaging the holder 50 from thevalve 20 and allowing the anchoring stent 24 to expand. FIG. 17B showsthe conversion of the anchoring stent 24 from its constricted to itsexpanded state and separation of the valve holder 50 from the heartvalve 20. This operation will occur after the valve 20 has been seatedat the target annulus. If this is the aortic annulus, conversion of thestent 24 causes it to expand outward into contact with the subvalvularstructure just below the annulus. The sealing ring 36 and to an extentthe sealing flange 28 contact the upper side of the aortic annulus, andthus the valve 20 is held in place. Additional sutures or clips may alsobe used.

FIG. 18A is an elevational view of the valve holder 50 secured to analternative hybrid prosthetic heart valve 120 using connecting sutures122, 124. The heart valve 120 is substantially the same as describedabove, through a sealing ring 126 has a substantially planar upper face128 and an undulating lower face 130 that matches the aortic annulus.Also, an anchoring stent 132 (shown without fabric covering for clarity)is modified from that shown above at 24 in FIGS. 1-2. Namely, ratherthan a series of axial struts with a chevron-shaped pattern ofcircumferential struts therebetween, as before, the stent 132 has aseries of crossed struts that define a regular array of diamond-shapedcells therebetween.

As described above, an upper connecting suture 122 secures three legs134 of the holder 50 to cusps of the valve 120. A lower connectingsuture 124 attaches to the holder (not shown) passes downward to a lowerend of the stent 132, and encircles and constricts the lower end whenunder tension. Both connecting sutures 122, 124 preferably pass over asingle cutting well on the holder to enable simultaneous severingthereof and detachment of the holder and expansion of the stent 132, asseen in FIG. 18B.

While the certain embodiments are described and illustrated herein, itis to be understood that the words and drawings that have been used arewords of description and not of limitation. Therefore, changes may bemade within the appended claims without departing from the true scope ofthe disclosure.

What is claimed is:
 1. A combination of a prosthetic heart valve forimplant at a heart valve annulus and a holder therefor, comprising: aprosthetic heart valve having a valve member with a non-expandable,non-collapsible annular support structure defining a flow orifice and aninflow end defining an inflow direction with an outflow directionopposite thereto, the valve member including valve leaflets attached tothe support structure and mounted to alternately open and close acrossthe flow orifice, and a self-expandable anchoring stent connected to thevalve member at the inflow end of the support structure, the anchoringstent having an inflow end projecting in the inflow direction away fromthe support structure; a valve holder having a central hub withstructure adapted to mate with a delivery handle; an upper connectingsuture attaching the valve holder to the prosthetic heart valve atmultiple locations; and a lower connecting suture attached to the valveholder and extending around the inflow end of the anchoring stent intension to constrict the inflow end from a relaxed size to a smallersize.
 2. The combination of claim 1, wherein the anchoring stent has afabric covering, and wherein the lower connecting suture passes throughthe fabric covering around the inflow end of the anchoring stent.
 3. Thecombination of claim 1, wherein the lower connecting suture passes overa cutting well on the valve holder such that severing the lowerconnecting suture at the cutting well releases the tension therein andpermits the inflow end of the anchoring stent to expand toward itsrelaxed size.
 4. The combination of claim 1, wherein both the lower andupper connecting sutures pass over a single cutting well on the valveholder such that severing the lower and upper connecting sutures at thesingle cutting well simultaneously releases the tension in the lowerconnecting suture and disconnects the valve holder from the prostheticheart valve.
 5. The combination of claim 1, wherein the valve holderincludes a plurality of legs that contact the valve member at themultiple locations having fabric incorporated into the valve member, andwherein the upper connecting suture passes circumferentially around thevalve holder and threads through the fabric at the multiple locations.6. The combination of claim 1, wherein the valve member supportstructure has three commissure posts projecting in the outflow directionand three cusps therebetween that arc in the inflow direction, and thevalve leaflets are flexible and partly supported by the commissure postsof the support structure, wherein the valve holder includes the centralhub and three legs that angle outward therefrom in the inflow directionto contact the valve member at the three cusps, and wherein the lowerconnecting suture is tied at two free ends to a terminal foot of one ofthe valve holder legs.
 7. The combination of claim 1, wherein the valvemember support structure has three commissure posts projecting in theoutflow direction and three fabric-covered cusps therebetween that arcin the inflow direction, and the valve leaflets are flexible and partlysupported by the commissure posts of the support structure, wherein thevalve holder includes the central hub and three legs that angle outwardtherefrom in the inflow direction to contact the valve member at thethree fabric-covered cusps, and wherein the upper connecting suturepasses circumferentially around the valve holder and threads through thefabric at the three cusps.
 8. The combination of claim 7, wherein theupper connecting suture is tied at first and second free ends to thevalve holder, and in between passes circumferentially around the centralhub of the valve holder and descends down each of the three legs to passthrough two holes at a terminal foot thereof, the upper connectingsuture being threaded through the fabric at each of the three cuspsbetween the two holes, and wherein the upper connecting suture circlescompletely around each leg between the hub and the respective foot. 9.The combination of claim 1, wherein the anchoring stent has a series ofcrossed struts that define a regular array of diamond-shaped cellstherebetween.
 10. A combination of a prosthetic heart valve for implantat a heart valve annulus and a holder therefor, comprising: a prostheticheart valve having a valve member with a non-expandable, non-collapsibleannular support structure defining a flow orifice and an inflow enddefining an inflow direction with an outflow direction opposite thereto,the valve member including valve leaflets attached to the supportstructure and mounted to alternately open and close across the floworifice, and a self-expandable anchoring stent projecting from the valvemember at the inflow end of the support structure, the anchoring stentbeing convertible between an outwardly expanded, relaxed shape and aninwardly compressed delivery shape; and a valve holder having a centralhub with structure adapted to mate with a delivery handle, the valveholder defining a cutting well; an upper connecting suture attaching thevalve holder to the prosthetic heart valve at multiple locations andlooped over the cutting well, wherein severing the upper connectingsuture simultaneously detaches the valve holder from the prostheticheart valve and converts the anchoring stent from its inwardlycompressed delivery shape toward its outwardly expanded, relaxed shape.11. The combination of claim 10, further including a lower connectingsuture attached to the valve holder and extending around an inflow endof the anchoring stent in tension to constrict the inflow end from itsoutwardly expanded, relaxed shape to its inwardly compressed deliveryshape, wherein severing the upper connecting suture also severs thelower connecting suture and releases the tension therein.
 12. Thecombination of claim 11, wherein the anchoring stent has a fabriccovering, and wherein the lower connecting suture passes through thefabric covering around the inflow end of the anchoring stent.
 13. Thecombination of claim 11, wherein both the lower and upper connectingsutures pass over the cutting well on the valve holder such thatsevering the lower and upper connecting sutures at the cutting wellsimultaneously releases the tension in the lower connecting suture anddisconnects the valve holder from the prosthetic heart valve.
 14. Thecombination of claim 11, wherein the valve member support structure hasthree commissure posts projecting in the outflow direction and threecusps therebetween that arc in the inflow direction, and the valveleaflets are flexible and partly supported by the commissure posts ofthe support structure, wherein the valve holder includes the central huband three legs that angle outward therefrom in the inflow direction tocontact the valve member at the three cusps, and wherein the lowerconnecting suture is tied at two free ends to a terminal foot of one ofthe valve holder legs.
 15. The combination of claim 11, wherein thelower connecting suture has a first free end attached to the valveholder, a middle portion that extends in a first length in the inflowdirection, in a second length around the entire inflow end of theanchoring stent, and in a third length back to the valve holderalongside the first length, the lower connecting suture further having afourth length that passes over the cutting well on the valve holder andends in a second free end attached to the valve holder such that whenthe two free ends are attached to the valve holder the first suture isunder tension and constricts the inflow end from its outwardly expanded,relaxed shape to its inwardly compressed delivery shape.
 16. Thecombination of claim 10, wherein the valve holder includes a pluralityof legs that contact the valve member at the multiple locations havingfabric incorporated into the valve member, and wherein the upperconnecting suture passes circumferentially around the valve holder andthreads through the fabric at the multiple locations.
 17. Thecombination of claim 10, wherein the valve member support structure hasthree commissure posts projecting in the outflow direction and threefabric-covered cusps therebetween that arc in the inflow direction, andthe valve leaflets are flexible and partly supported by the commissureposts of the support structure, wherein the valve holder includes thecentral hub and three legs that angle outward therefrom in the inflowdirection to contact the valve member at the three fabric-covered cusps,and wherein the upper connecting suture passes circumferentially aroundthe valve holder and threads through the fabric at the three cusps. 18.The combination of claim 17, wherein the upper connecting suture is tiedat first and second free ends to the valve holder, and in between passescircumferentially around the central hub of the valve holder anddescends down each of the three legs to pass through two holes at aterminal foot thereof, the upper connecting suture being threadedthrough the fabric at each of the three cusps between the two holes, andwherein the upper connecting suture circles completely around each legbetween the hub and the respective foot.
 19. The combination of claim10, wherein the anchoring stent has a series of crossed struts thatdefine a regular array of diamond-shaped cells therebetween.
 20. Thecombination of claim 10, wherein the anchoring stent has an outflow endconnected to the valve member at the inflow end of the support structureand having a generally fixed dimension, and an inflow end projecting inthe inflow direction away from the support structure that is constrictedto a first diameter when the anchoring stent is in its inwardlycompressed delivery shape and is expanded to a larger diameter when theanchoring stent is in its outwardly expanded, relaxed shape, theanchoring stent converting between two generally conical shapes.